Inclusion criteria in BE studies [Design Issues]

posted by jag009  – NJ, 2020-05-25 05:43 (387 d 01:33 ago) – Posting: # 21460
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» In BE studies, in case the participants are both males and females, should the ratio between them be 1:1 or any ratio is accepted, also for randomization procedure is there any special requirements in case both included?

You should aim for 1:1 in the protocol but say at least 60:40 split (you can try 70:30 if you are desperate). I do that on my protocols for many yrs and no problem w FDA.

You should randomize w gender as well. I had one CRO who put the first 10 as males and then last 10 as females, lol. No I did not find that funny when I spoke w them.


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